SMITH & NEPHEW, INC. TWINFIX TI 2.8 DURABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72200762 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that during an arthroscopy, the shaft of twinfix was found to be engraved with four laser marks, instead of two laser marks.It is unknown how the procedure was completed or if there was a delay.No patient complications were reported.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the shaft drawing found that there are two axial laser marks 180° apart that correspond to the center of the opposite flats on the hex.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and the anchor and sutures were not returned.There is debris on the device.There are four laser vertical laser markings on the shaft of the device.Two markings on each side, approximately 180° apart.The markings are worn and scuffed.The complaint was confirmed, and the root cause was associated with manufacturing.A quality alert has been issued in response to this event.
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Search Alerts/Recalls
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